Trial Outcomes & Findings for Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer (NCT NCT03215810)

Last Updated: 2023-07-24

Results Overview

Investigators plan to demonstrate that treatment with nivolumab in patients undergoing TIL therapy is safe with a continuous Pocock-type stopping boundary for serious toxicity of \< 17%, with safety reported based upon Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria. DLT defined as: any grade ≥3 immune-related adverse event definitely attributable to nivolumab. DLT related to adoptive cell therapy will be defined as a non-hematologic grade 4 or higher adverse event that is immediately life-threatening occurring upon or after the start of therapy that is immediately life-threatening and not related to non-small cell lung cancer or other pre-existing condition. Safety: Toxicity will be assessed within 4 weeks of the adoptive TIL transfer. The accrual will be halted if excessive numbers of participants with toxicity are seen. For example, if there are 5 or more out of 10 participants (full follow-up) with toxicity, the trial will be stopped.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Up to 40 months

Results posted on

2023-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	TIL+ Nivolumab Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	TIL+ Nivolumab Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
Overall Study Still responding to nivolumab	1
Overall Study Insufficient TIL growth	1
Overall Study Decline in performance status	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TIL+ Nivolumab n=20 Participants Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	6 Participants n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	20 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 40 months

Population: All participants evaluable for safety

Outcome measures

Outcome measures
Measure	TIL+ Nivolumab n=16 Participants Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
Rate of Dose Limiting Toxicity (DLT)	17 % participants w severe toxicity

SECONDARY outcome

Timeframe: Up to 40 months

Population: Participants evaluable for response

Participants displaying objective response associated with the treatment regimen per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.

Outcome measures

Outcome measures
Measure	TIL+ Nivolumab n=13 Participants Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
Number of Participants With Objective Response Confirmed	3 Participants
Number of Participants With Objective Response Unconfirmed	3 Participants

Adverse Events

TIL+ Nivolumab

Serious events: 15 serious events

Other events: 20 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	TIL+ Nivolumab n=20 participants at risk Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 2/20 • Number of events 5 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 4/20 • Number of events 5 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Blood and lymphatic system disorders Febrile neutropenia	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Immune system disorders Cytokine release syndrome	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Lung infection	20.0% 4/20 • Number of events 5 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Sepsis	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Upper respiratory infection	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Vascular disorders Thromboembolic event	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Renal and urinary disorders Urinary retention	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Pneumothorax	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hyponatremia	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Cardiac disorders Pericardial effusion	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Pulmonary edema	15.0% 3/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Non-cardiac chest pain	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Pain	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Blood and lymphatic system disorders Anemia	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Fever	15.0% 3/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Platelet count decreased	10.0% 2/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Chills	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Vascular disorders Hematoma	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Stroke	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Infusion related reaction	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Death NOS	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Infections and Infestations - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Psychiatric disorders Psychiatric disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Hypoxia	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hyperglycemia	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Infections and infestations -Other	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade

Other adverse events

Other adverse events
Measure	TIL+ Nivolumab n=20 participants at risk Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
Gastrointestinal disorders Abdominal pain	15.0% 3/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Activated partial thromboplastin time prolonged	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Renal and urinary disorders Acute kidney injury	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Alanine aminotransferase increased	50.0% 10/20 • Number of events 23 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Alkaline phosphatase increased	70.0% 14/20 • Number of events 34 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Blood and lymphatic system disorders Anemia	85.0% 17/20 • Number of events 151 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Anorexia	50.0% 10/20 • Number of events 11 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Psychiatric disorders Anxiety	20.0% 4/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 4/20 • Number of events 8 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Aspartate aminotransferase increased	55.0% 11/20 • Number of events 23 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Aspiration	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Atelectasis	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Back pain	30.0% 6/20 • Number of events 6 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Bloating	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	10.0% 2/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Blood bilirubin increased	15.0% 3/20 • Number of events 5 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Bone pain	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Bronchospasm	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Skin and subcutaneous tissue disorders Bullous dermatitis	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Cardiac disorders Cardiac disorders - Other	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Chills	40.0% 8/20 • Number of events 13 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Cholesterol high	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Psychiatric disorders Confusion	15.0% 3/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Eye disorders Conjunctivitis	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Constipation	45.0% 9/20 • Number of events 16 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Cough	40.0% 8/20 • Number of events 14 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Creatinine increased	30.0% 6/20 • Number of events 9 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Immune system disorders Cytokine release syndrome	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Dehydration	20.0% 4/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Psychiatric disorders Delirium	15.0% 3/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Psychiatric disorders Depression	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Injury, poisoning and procedural complications Dermatitis radiation	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Diarrhea	80.0% 16/20 • Number of events 30 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Dizziness	25.0% 5/20 • Number of events 6 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Eye disorders Dry eye	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Dry mouth	40.0% 8/20 • Number of events 9 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Skin and subcutaneous tissue disorders Dry skin	15.0% 3/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Dysgeusia	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Dyspepsia	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Dysphagia	30.0% 6/20 • Number of events 7 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Dyspnea	70.0% 14/20 • Number of events 21 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Edema cerebral	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Edema limbs	45.0% 9/20 • Number of events 9 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Electrocardiogram QT corrected interval prolonged	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Endocrine disorders Endocrine disorders - Other	10.0% 2/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Eye disorders Eye disorders - Other	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Eye disorders Eye pain	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Fatigue	60.0% 12/20 • Number of events 21 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Blood and lymphatic system disorders Febrile neutropenia	15.0% 3/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Fever	50.0% 10/20 • Number of events 31 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Flank pain	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Flu like symptoms	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Vascular disorders Flushing	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Gastritis	15.0% 3/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Gastrointestinal disorders - Other	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders General disorders and administration site conditions - Other	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Generalized muscle weakness	15.0% 3/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Reproductive system and breast disorders Genital edema	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Headache	35.0% 7/20 • Number of events 10 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Renal and urinary disorders Hematuria	25.0% 5/20 • Number of events 8 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Hemoglobin increased	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Hiccups	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Vascular disorders Hot flashes	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hypercalcemia	15.0% 3/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hyperglycemia	50.0% 10/20 • Number of events 47 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Skin and subcutaneous tissue disorders Hyperhidrosis	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hyperkalemia	65.0% 13/20 • Number of events 40 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hypermagnesemia	50.0% 10/20 • Number of events 19 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hypernatremia	10.0% 2/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Vascular disorders Hypertension	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Endocrine disorders Hyperthyroidism	20.0% 4/20 • Number of events 5 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hypoalbuminemia	85.0% 17/20 • Number of events 64 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hypocalcemia	60.0% 12/20 • Number of events 54 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hypokalemia	30.0% 6/20 • Number of events 9 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hypomagnesemia	10.0% 2/20 • Number of events 6 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hyponatremia	65.0% 13/20 • Number of events 52 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Hypophosphatemia	65.0% 13/20 • Number of events 41 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Vascular disorders Hypotension	50.0% 10/20 • Number of events 17 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Endocrine disorders Hypothyroidism	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Hypoxia	45.0% 9/20 • Number of events 16 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Infections and infestations - Other	15.0% 3/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Infusion related reaction	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations INR increased	45.0% 9/20 • Number of events 20 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Psychiatric disorders Insomnia	30.0% 6/20 • Number of events 8 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Investigations - Other	25.0% 5/20 • Number of events 18 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Reproductive system and breast disorders Irregular menstruation	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Joint effusion	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Joint range of motion decreased	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Blood and lymphatic system disorders Leukocytosis	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Lung infection	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Lymphocyte count decreased	90.0% 18/20 • Number of events 132 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Lymphocyte count increased	10.0% 2/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Memory impairment	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Reproductive system and breast disorders Menorrhagia	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Mucositis oral	20.0% 4/20 • Number of events 5 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	10.0% 2/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Nausea	75.0% 15/20 • Number of events 28 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Nervous system disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Neutrophil count decreased	75.0% 15/20 • Number of events 50 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Non-cardiac chest pain	20.0% 4/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Oral hemorrhage	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Osteoporosis	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
General disorders Pain	50.0% 10/20 • Number of events 17 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Skin and subcutaneous tissue disorders Pain of skin	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Reproductive system and breast disorders Pelvic pain	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Cardiac disorders Pericarditis	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Peripheral sensory neuropathy	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Platelet count decreased	75.0% 15/20 • Number of events 111 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Pleural effusion	30.0% 6/20 • Number of events 6 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Productive cough	35.0% 7/20 • Number of events 7 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Renal and urinary disorders Proteinuria	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Skin and subcutaneous tissue disorders Pruritus	25.0% 5/20 • Number of events 6 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Psychiatric disorders Psychiatric disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Pulmonary edema	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Skin and subcutaneous tissue disorders Rash acneiform	20.0% 4/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Skin and subcutaneous tissue disorders Rash maculo-papular	35.0% 7/20 • Number of events 11 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Renal and urinary disorders Renal and urinary disorders - Other	10.0% 2/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	25.0% 5/20 • Number of events 7 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Rhinitis infective	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Seizure	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Cardiac disorders Sinus tachycardia	55.0% 11/20 • Number of events 18 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Sinusitis	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	15.0% 3/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Sore throat	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Stroke	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Psychiatric disorders Suicidal ideation	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Vascular disorders Thromboembolic event	20.0% 4/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Toothache	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Tremor	5.0% 1/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Upper respiratory infection	10.0% 2/20 • Number of events 3 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Renal and urinary disorders Urinary frequency	15.0% 3/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Renal and urinary disorders Urinary incontinence	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Urinary tract infection	15.0% 3/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Renal and urinary disorders Urinary urgency	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Skin and subcutaneous tissue disorders Urticaria	5.0% 1/20 • Number of events 2 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Infections and infestations Vaginal infection	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Nervous system disorders Vasovagal reaction	5.0% 1/20 • Number of events 1 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Gastrointestinal disorders Vomiting	40.0% 8/20 • Number of events 10 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations Weight loss	20.0% 4/20 • Number of events 8 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Respiratory, thoracic and mediastinal disorders Wheezing	15.0% 3/20 • Number of events 4 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade
Investigations White blood cell decreased	90.0% 18/20 • Number of events 97 • Adverse events were collected for 2 years and 11 months Adverse Events includes all enrolled patients who started initial nivolumab (20) but only 16 received TIL. Therefore the denominator (20) includes all enrolled patients exposed to any study tx. This table is intended to represent a summary-level overview for all patients enrolled on the trial, and not intended to indicate attribution, frequency, or causality for specific drugs or TIL. Please refer to the publication for dedicated adverse event tables, including grade

Additional Information

Ben Creelan, MD

Moffitt Cancer Center

Phone: 813-745-4541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60